ORBIT GALAXY XTRASOFTRecalls & reported problems across all models

We found 18 models of ORBIT GALAXY XTRASOFT by Medos International Sàrl in the FDA's device registry (GUDID). Together they are named in 320 adverse event reports in the FDA's MAUDE database, received between Sep 14, 2016 and Sep 9, 2026 — classified as 2 deaths, 20 injuries, 298 malfunctions.

The most frequently reported specific device problem is “Stretched” (119 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported ORBIT GALAXY XTRASOFT problems

ORBIT GALAXY XTRASOFT models

18 models, most reported first. Each model has its own page with its reports, recalls and device details.

• ORBIT GALAXY XTRASOFT 640CX0306

  Device, Vascular, for Promoting Embolization
  41 reports
• ORBIT GALAXY XTRASOFT 640CX2505

  Device, Vascular, for Promoting Embolization
  35 reports
• ORBIT GALAXY XTRASOFT 640CX0308

  DEVICE, NEUROVASCULAR EMBOLIZATION
  31 reports
• ORBIT GALAXY XTRASOFT 640CX0408

  DEVICE, NEUROVASCULAR EMBOLIZATION
  30 reports
• ORBIT GALAXY XTRASOFT 640CX3575

  Device, Vascular, for Promoting Embolization
  1 death25 reports
• ORBIT GALAXY XTRASOFT 640CX0202

  DEVICE, NEUROVASCULAR EMBOLIZATION
  21 reports
• ORBIT GALAXY XTRASOFT 640CX2535

  Device, Vascular, for Promoting Embolization
  19 reports
• ORBIT GALAXY XTRASOFT 640HX0206

  DEVICE, NEUROVASCULAR EMBOLIZATION
  19 reports
• ORBIT GALAXY XTRASOFT 640CX3509

  Device, Vascular, for Promoting Embolization
  18 reports
• ORBIT GALAXY XTRASOFT 640HX0204

  Device, Vascular, for Promoting Embolization
  17 reports
• ORBIT GALAXY XTRASOFT 640CX0304

  Device, Vascular, for Promoting Embolization
  15 reports
• ORBIT GALAXY XTRASOFT 640CX0410

  Device, Vascular, for Promoting Embolization
  1 death12 reports
• ORBIT GALAXY XTRASOFT 640CX3505

  DEVICE, NEUROVASCULAR EMBOLIZATION
  12 reports
• ORBIT GALAXY XTRASOFT 640CX0406

  Device, Vascular, for Promoting Embolization
  9 reports
• ORBIT GALAXY XTRASOFT 640HX0208

  Device, Vascular, for Promoting Embolization
  7 reports
• ORBIT GALAXY XTRASOFT 640CX2525

  Device, Vascular, for Promoting Embolization
  5 reports
• ORBIT GALAXY XTRASOFT 640CX0201

  DEVICE, NEUROVASCULAR EMBOLIZATION
  3 reports
• ORBIT GALAXY XTRASOFT 640CX0404

  Device, Vascular, for Promoting Embolization
  1 report

Recent ORBIT GALAXY XTRASOFT adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 9, 2026Separation Failure

  A healthcare professional reported that during an aneurysm embolization, an unspecified microcatheter was in place and an ORBIT GALAXY XTRASOFT (product code: 640CX0404, lot number: 31471128) coil was delivered to target site. The coil was packed in the aneurysm and tried to detach, but the coil was unable to detach. The doctor only retracted the coil alone and switched to a new one to complete the surgery. The microcatheter was not replaced. There was no patient injury reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50694662 ↗
• MalfunctionJun 19, 2026Failure to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION, THE PHYSICIAN DELIVERED AN ORBIT GALAXY XTRASOFT COIL (PRODUCT CODE: 640CX0408, LOT NUMBER: 31763941) IN A COMPETITOR¿S MICROCATHETER. THE COIL BECAME WAS IMPEDED IN THE PROXIMAL END OF THE MICROCATHETER AND COULD NOT ADVANCE ANY MORE. THE PHYSICIAN ONLY RETRACTED THE COIL ALONE AND SWITCHED TO A COMPETITOR¿S COIL TO COMPLETE THE PROCEDURE. THE MICROCATHETERS WERE NOT REPLACED. THERE WAS NO PATIENT INJURY REPORTED. ADDITIONAL INFORMATION RECEIVED INDICATED THAT NO PATIENT INJURY WAS ALLEGED IN ASSOCIATION WITH THE REPORTED EVENT. THE MICROCATHETER USED WAS A PROWLER SELECT PLUS 150/5CM (PRODUCT CODE: 606S255X). NO OTHER DEVICES WERE USED IN CONJUNCTION WITH THE MICROCATHETER BEFORE OR AFTER THE REPORTED RESISTANCE. THE TARGET VESSEL WAS THE M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY, AND NO RELEVANT ANATOMICAL FACTORS WERE REPORTED. THE DEVICE DID NOT APPEAR DAMAGED AT ANY TIME DURING THE PROCEDURE. CONTINUOUS FLUSH WAS MAINTAINED, AND IT WAS CONFIRMED THAT THE INTRODUCER TIP WAS PROPERLY INSTALLED INTO THE MICROCATHETER HUB AND SECURED WITH THE RHV DURING DEVICE ADVANCEMENT. BASED ON THE PRODUCT ANALYSIS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25563659 ↗
• MalfunctionJun 12, 2026Material Twisted/Bent

  IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, THE COIL WERE ON THE 3.5MM X 7.5CM ORBIT GALAXY COMPLEX XTRASOFT COIL (640CX3575 / 31586977) WAS KINKED WHEN THE PHYSICIAN TRIED TO INTRODUCE THE COIL INTO THE MICROCATHETER. THE COIL WAS SUCCESSFULLY REMOVED BEFORE IT WAS INTO A PATIENT'S BODY. THE PATIENT REMAINS ASYMPTOMATIC. THE PROCEDURE WAS SUCCESSFULLY DONE. MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION RELATED TO THE PROCEDURE AND THE REPORTED DEVICE ISSUE WERE UNSUCCESSFUL. IF ADDITIONAL INFORMATION IS RECEIVED AT A LATER DATE, THIS FILE WILL BE UPDATED ACCORDINGLY. THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION AND ANALYSIS. THE PRODUCT INVESTIGATION COMPLETED ON 12-JUN-2026. BASED ON THE COMPLETED PRODUCT INVESTIGATION, THIS EVENT HAS BEEN DETERMINED TO BE USFDA REPORTABLE UNDER 21 CFR 803 WITH A CLASSIFICATION OF ¿MALFUNCTION.¿.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25490662 ↗
• MalfunctionJun 8, 2026Separation Failure

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING A COIL EMBOLIZATION, AN ORBIT GALAXY XTRASOFT COIL (PRODUCT CODE: 640CX0408, LOT NUMBER: 31606037) WAS PACKED IN THE ANEURYSM AND TRIED TO DETACH, BUT THE COIL WAS UNABLE TO DETACH. DOCTOR ONLY RETRACTED THE COIL ALONE AND SWITCHED A NEW COIL TO COMPLETE THE SURGERY. THE COIL MICROCATHETER (COMPETITOR¿S BRAND) WAS NOT REPLACED. ADDITIONAL EVENT INFORMATION RECEIVED ON 05-JUN-2026 INDICATED THAT A PRE-DEPLOYMENT ELECTRICAL TESTING WAS PERFORMED. THE SAME DCB AND CONTROL CABLE WERE USED SUCCESSFULLY WITH SUBSEQUENT COILS. THE COIL WAS STILL ATTACHED TO THE COIL DELIVERY SYSTEM WHEN REMOVED FROM THE PATIENT. THE EMBOLIC COIL DID NOT STRETCH OR BECAME DAMAGED WHEN REMOVED FROM THE PATIENT. THERE WAS NO PROCEDURE PROLONGATION/DELAY DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25430449 ↗
• MalfunctionJun 4, 2026Stretched

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION TO A POSTERIOR COMMUNICATING ARTERY ANEURYSM, AN ENTERPRISE2 4MMX16MM VASCULAR RECONSTRUCTION DEVICE (PRODUCT CODE: ENCR401612, LOT NUMBER: 9854670) WAS IMPEDED IN DISTAL END OF A PROWLER SELECT PLUS 150/5CM MICROCATHETER (PRODUCT CODE: 606S255X, LOT NUMBER: 31700153) AND COULD NOT PASS THROUGH THE MICROCATHETER (MC). THE DOCTOR DIRECTLY REMOVED THE STENT AND MICROCATHETER TOGETHER FROM THE PATIENT AND SWITCHED A NEW STENT AND A NEW MICROCATHETER TO CONTINUE THE SURGERY. WHEN PACKING COIL IN THE ANEURYSM, A 3.5X9 ORBIT GALAXY XTRASOFT (PRODUCT CODE: 640CX3509, LOT NUMBER: 31651282) WAS UNABLE TO ROTATE RANDOMLY, THE DOCTOR ONLY RETRACTED THE COIL, IT WAS FOUND THAT THE COIL HAD BEEN UNRAVELED/STRETCHED. THE DOCTOR SWITCHED TO A SECOND COIL, A 3.5X5 ORBIT GALAXY XTRASOFT (PRODUCT CODE: 640CX3505, LOT NUMBER: 31527069) WHICH BECAME IMPEDED IN THE PROXIMAL END OF THE COIL MICROCATHETER (COMPETITOR¿S BRAND) AND COULD NOT ADVANCE ANY MORE. THE DOCTOR ONLY RETRACTED THE SECOND COIL AND FOUND THE DELIVERY WIRE OF THE SECOND COIL WAS KINKED/BENT. THE DOCTOR SWITCHED A THIRD COIL (COMPETITOR¿S BRAND) TO COMPLETE THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25392878 ↗
• DeathMay 28, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE ON (B)(6) 2026, TARGETING AN ANEURYSM ON THE ANTERIOR COMMUNICATING ARTERY, THE FIRST COIL, A 4MM X 10CM ORBIT GALAXY COMPLEX XTRASOFT (640CX0410 / 31770622) AND THE SECOND COIL, A 3.5MM X 7.5CM ORBIT GALAXY COMPLEX XTRASOFT (640CX3575 / 31770623) WERE PACKED WITHIN THE ANEURYSM. SUBSEQUENTLY, WHILE PACKING THE ANEURYSM WITH COILS FROM OTHER BRANDS, THE ANEURYSM RUPTURED AND BLEEDING WAS OBSERVED. THE PHYSICIAN IMPLANTED TWO STENTS (FROM OTHER MANUFACTURERS). A CRANIOTOMY WAS PERFORMED THEREAFTER. ON (B)(6) 2026, ADDITIONAL INFORMATION WAS RECEIVED. PER THE INFORMATION, THE ANEURYSM RUPTURED AFTER THE FIRST AND SECOND COIL WERE IMPLANTED AND DURING THE PACKING OF THE ANEURYSM WITH NON-CERENOVUS COILS. THE INFORMATIONAL ALSO INDICATED THAT THE PATIENT IS DECEASED; THE EXACT DATE OF DEATH IS UNKNOWN. THE PHYSICIAN CONSIDERED THE ANEURYSM RUPTURE TO BE UNRELATED TO CERENOVUS COILS. THERE WAS NO DELAY TO THE ENDOVASCULAR EMBOLIZATION PROCEDURE.

  Patient problems: Intracranial Hemorrhage; Ruptured Aneurysm

  MAUDE report 25321571 ↗
• DeathMay 28, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE ON (B)(6) 2026, TARGETING AN ANEURYSM ON THE ANTERIOR COMMUNICATING ARTERY, THE FIRST COIL, A 4MM X 10CM ORBIT GALAXY COMPLEX XTRASOFT (640CX0410 / 31770622) AND THE SECOND COIL, A 3.5MM X 7.5CM ORBIT GALAXY COMPLEX XTRASOFT (640CX3575 / 31770623) WERE PACKED WITHIN THE ANEURYSM. SUBSEQUENTLY, WHILE PACKING THE ANEURYSM WITH COILS FROM OTHER BRANDS, THE ANEURYSM RUPTURED AND BLEEDING WAS OBSERVED. THE PHYSICIAN IMPLANTED TWO STENTS (FROM OTHER MANUFACTURERS). A CRANIOTOMY WAS PERFORMED THEREAFTER. ON 27-MAY-2026, ADDITIONAL INFORMATION WAS RECEIVED. PER THE INFORMATION, THE ANEURYSM RUPTURED AFTER THE FIRST AND SECOND COIL WERE IMPLANTED AND DURING THE PACKING OF THE ANEURYSM WITH NON-CERENOVUS COILS. THE INFORMATIONAL ALSO INDICATED THAT THE PATIENT IS DECEASED; THE EXACT DATE OF DEATH IS UNKNOWN. THE PHYSICIAN CONSIDERED THE ANEURYSM RUPTURE TO BE UNRELATED TO CERENOVUS COILS. THERE WAS NO DELAY TO THE ENDOVASCULAR EMBOLIZATION PROCEDURE.

  Patient problems: Intracranial Hemorrhage; Ruptured Aneurysm

  MAUDE report 25321570 ↗
• MalfunctionApr 14, 2026Device Difficult to Setup or Prepare

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRACRANIAL COIL EMBOLIZATION PROCEDURE ON (B)(6) 2026, A 3.5MM X 7.5CM ORBIT GALAXY COMPLEX XTRASOFT COIL (640CX3575 / 31593818) WAS USED, AND IT COULD NOT BE RE-SHEATHED. THE COIL WAS REPLACED. THE PROCEDURE WAS DELAYED BY ABOUT 5 MINUTES. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION RELATED TO THE PROCEDURE AND THE REPORTED DEVICE ISSUE WERE UNSUCCESSFUL. IF ADDITIONAL INFORMATION IS RECEIVED AT A LATER DATE, THIS FILE WILL BE UPDATED ACCORDINGLY. THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION AND ANALYSIS. BASED ON THE RESULT OF THE PRODUCT ANALYSIS COMPLETED ON 14-APR-2026, THE EVENT HAS BEEN DETERMINED TO BE USFDA MDR REPORTABLE AS A "MALFUNCTION."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24879767 ↗
• MalfunctionApr 2, 2026Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A STENT-ASSISTED ENDOVASCULAR EMBOLIZATION PROCEDURE ON (B)(6) 2026, THE MICROCATHETER WAS IN PLACE AND THE 8MM X 24CM ORBIT GALAXY COMPLEX FILL (640CF0824 / 31651278) WAS DELIVERED TO THE TARGET SITE. THE COIL FILLED THE ANEURYSM, AND THE PHYSICIAN TRIED TO DETACH THE COIL, BUT THE COIL WAS UNABLE TO BE DETACHED. THE PHYSICIAN RETRACTED ONLY THE COIL AND REPLACED IT WITH A SECOND COIL, A 2.5MM X 5CM ORBIT GALAXY COMPLEX XTRASOFT (640CX2505 / 31661861). THE SECOND COIL ENCOUNTERED THE SAME ISSUE; IT WAS UNABLE TO BE DETACHED. THE PHYSICIAN RETRACTED THE COIL AND REPLACED IT WITH A THIRD COIL FROM ANOTHER MANUFACTURER TO COMPLETE THE PROCEDURE USING THE ORIGINAL MICROCATHETER. THERE WAS NO REPORT OF ANY NEGATIVE IMPACT ON THE PATIENT. ON 01-APR-2026, ADDITIONAL INFORMATION WAS RECEIVED. PER THE INFORMATION, THE PROCEDURE WAS A STENT-ASSISTED COIL EMBOLIZATION OF AN ANEURYSM ON THE INTERNAL CAROTID ARTERY. THE COILS WERE NOT STRETCHED WHEN THEY WERE REMOVED; THEY WERE STILL ATTACHED TO THE DELIVERY SYSTEMS. THERE WAS NO INTERRUPTION OF BLOOD FLOW. THE SYRINGE WAS FILLED WITH SALINE FROM A DEDICATED SOURCE. THE SAME SYRINGE WAS USED WIT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24767328 ↗
• MalfunctionFeb 25, 2026Entrapment of Device; Failure to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A COIL EMBOLIZATION, RESISTANCE WAS ENCOUNTERED WHEN ATTEMPTING TO ADVANCE AN ORBIT GALAXY XTRASOFT COIL (PRODUCT CODE: 640HX0206, LOT NUMBER 31651283) THROUGH A NON J&J MICROCATHETER. THE COIL WAS UNABLE TO PASS THE DISTAL END OF THE MICROCATHETER (MC). UNDER FLUOROSCOPY, THE COIL APPEARED CLUSTERED INSIDE THE MICROCATHETER. THE PHYSICIAN RETRACTED AND REMOVED ONLY THE COIL, THEN REPLACED IT WITH A NEW COIL TO SUCCESSFULLY COMPLETE THE PROCEDURE. THE MICROCATHETER WAS NOT REPLACED, AND NO PATIENT INJURY WAS REPORTED. ADDITIONAL EVENT INFORMATION RECEIVED ON 24-FEB-2026 INDICATED THAT THEY COULD NOT MOVE THE DEVICE AT ALL DUE TO THE RESISTANCE. THEY WERE NOT ABLE TO TORQUE THE DEVICE. THERE WAS NO EVIDENCE OF PHYSICAL MATERIAL WITHIN THE DEVICE. THE DEVICE NOR THE CONCOMITANT DEVICE KINKED OR BENT PRIOR TO THE RESISTANCE OR NOTED AFTER REMOVAL FROM THE PATIENT. THE COIL HAD NOT BEEN WITHDRAWN OR REPOSITIONED. NECK REMODELING WAS NOT UTILIZED. THERE WAS NO ALLEGATION OF PATIENT INJURY DUE TO AN ALLEGED PRODUCT ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24443159 ↗
• MalfunctionJan 28, 2026Retraction Problem

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A COIL EMBOLIZATION, AN ORBIT GALAXY XTRASOFT COIL (PRODUCT CODE: 640CX2535, LOT NUMBER: UNKNOWN) COULDN'T BE ADVANCED NOR RETRIEVED BY THE PHYSICIAN. THIS WAS THE FIRST COIL. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24199819 ↗
• MalfunctionJan 14, 2026Stretched

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING A COIL EMBOLIZATION, A 2X4 ORBIT GALAXY XTRASOFT COIL (640HX0204, 31722202) WAS UNRAVELED OR STRETCHED. THE COIL'S SHAPE WAS FOUND TO BE NOT IDEAL WHILE FILLING THE TARGET SITE, LEADING THE PHYSICIAN TO RETRACT THE COIL, AT WHICH POINT THE DEVICE WAS OBSERVED TO BE UNRAVELED/STRETCHED. THE PHYSICIAN COMPLETED THE PROCEDURE USING A COIL FROM ANOTHER BRAND, AND THE MICROCATHETER WAS NOT REPLACED. THERE WERE NO REPORTED CONSEQUENCES OR IMPACT TO THE PATIENT, AND NO SIGNS, SYMPTOMS, OR PATIENT INVOLVEMENT WERE IDENTIFIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24067813 ↗
• MalfunctionDec 4, 2025Separation Failure; Separation Failure

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING A COIL EMBOLIZATION, A 3X8 ORBIT GALAXY XTRASOFT COIL (PRODUCT CODE 640CX0308, LOT NUMBER 31634774) FAILED TO DETACH. THE COIL WAS DELIVERED TO THE TARGET SITE AND FILLED THE ANEURYSM, BUT DETACHMENT COULD NOT BE ACHIEVED. THE PHYSICIAN RETRACTED THE COIL AND USED A NEW ONE TO COMPLETE THE SURGERY, WITHOUT REPLACING THE UNSPECIFIED MICROCATHETER. THERE WAS NO REPORTED PATIENT CONSEQUENCE OR CLINICAL IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23716544 ↗
• MalfunctionDec 3, 2025Stretched; Stretched

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, THE SHAPE OF THE 3MM X 6CM ORBIT GALAXY COMPLEX XTRASOFT (640CX0306 / 31485464) WAS FOUND TO BE NOT IDEAL AFTER IT WAS USED TO FILL THE ANEURYSM. THE PHYSICIAN RETRACTED ONLY THE COIL, BUT THE OIL WAS FOUND TO BE UNRAVELED / STRETCHED. THE PHYSICIAN REPLACED THE COIL WITH ONE FROM ANOTHER BRAND TO COMPLETE THE PROCEDURE USING THE SAME ORIGINAL MICROCATHETER (UNSPECIFIED BRAND). THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. ON 26-NOV-2025, ADDITIONAL INFORMATION WAS RECEIVED. PER THE INFORMATION, THE PROCEDURE WAS TARGETING A TORTUOUS AND NARROW ANEURYSM ON THE LEFT INTERNAL CAROTID ARTERY. NO NECK REMODELING WAS USED; A CONTINUOUS FLUSH HAD BEEN MAINTAINED THROUGH THE MICROCATHETER. THE COIL HAD BEEN WITHDRAWN AND REPOSITIONED (THE NUMBER OF TIMES THIS HAD BEEN DONE WAS NOT PROVIDED). THERE WAS NO RESISTANCE BETWEEN THE GUIDEWIRE AND THE MICROCATHETER WHEN THE TARGET SITE WAS BEING ACCESSED. PRIOR TO THIS COIL, ONE OTHER COIL WENT THROUGH THE MICROCATHETER WITHOUT RESISTANCE. INFORMATION RELATED TO COIL ENTANGLEMENT WITH PREVIOUSLY PLACED COIL COULD NOT BE OBTAINED. THERE WAS NO ADDITIONA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23707851 ↗
• MalfunctionNov 21, 2025Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A STENT-ASSISTED EMBOLIZATION OF A RIGHT MIDDLE CEREBRAL ARTERY ANEURYSM, THE MICROCATHETER (UNSPECIFIED BRAND) WAS IN PLACE AND THE FIRST COIL, A 2MM X 6CM ORBIT GALAXY HELICAL XTRASOFT (640HX0206 / 31467317) WAS DELIVERED TO THE TARGET. THE COIL FILLED THE ANEURYSM, AND THE PHYSICIAN TRIED TO DETACH THE COIL, BUT IT WAS UNABLE TO DETACH. THE PHYSICIAN RETRACTED ONLY THE COIL AND REPLACED IT WITH A SECOND COIL. THE SECOND COIL WAS PLACED AND DETACHED. A THIRD COIL, A 4MM X 10CM ORBIT GALAXY COMPLEX XTRASOFT (640CX0410 / 31567754) WAS INTRODUCED INTO THE ANEURYSM, AND THIS THIRD COIL WAS ALSO UNABLE TO BE DETACHED. THE PHYSICIAN RETRACTED THE COIL AND REPLACED IT TO COMPLETE THE PROCEDURE USING THE SAME ORIGINAL CONCOMITANT MICROCATHETER. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. ON 19-NOV-2025, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION CONFIRMED THE PROCEDURE WAS A STENT-ASSISTED EMBOLIZATION OF A RIGHT MIDDLE CEREBRAL ARTERY ANEURYSM. THE COILS WERE NOT STRETCHED WHEN THEY WERE REMOVED; BOTH COILS WERE STILL ATTACHED TO THEIR RESPECTIVE DELIVERY SYSTEMS. THERE WAS NO EVIDENCE OF ANY BLOOD FLOW RESTRICTION / INT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23624782 ↗

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